A Phase II Randomized Controlled Trial: Definitive Concurrent Chemoradiotherapy with Docetaxel Plus Cisplatin versus 5-Fluorouracil plus Cisplatin in Patients with Oesophageal Squamous Cell Carcinoma

Abstract

Purpose: To evaluate the efficacy and toxicity of definitive concurrent chemoradiotherapy (CCRT) with docetaxel plus cisplatin (DP regimen) versus 5-fluorouracil plus cisplatin (PF regimen) in patients with oesophageal squamous cell carcinoma (ESCC). Patients and Methods: In this phase II randomized controlled trial, eighty-six patients with clinical stage II - IVa ESCC were randomized to receive radiotherapy concurrently with two cycles of the PF or DP regimen at 3-week intervals. The primary endpoint was overall survival (OS). The secondary end points included the overall response rate (ORR), progression-free survival (PFS) and treatment-related toxicities. Results: The ORRs were 84.4% in the DP group and 87.3% in the PF group (P = 0.653). After a median follow-up time of 25.1 months, the 1- and 2-year OS rates were 93.7% and 86.2% for the PF group and 87.3% and 69.1% for the DP group, respectively (P = 0.364). The 1- and 2-year PFS rates were 77.4% and 55.0% for the PF group and 78.8% and 69.4% for the DP group, respectively (P = 0.845). Grade 3/4 leukocytopenia/neutropenia (68.9% vs. 19.5%, P < 0.001) was significantly more common in the DP group. Conclusion: The treatment response, OS and PFS associated with using CCRT with the DP regimen were not superior to those associated with using CCRT with the PF regimen as a first-line treatment in patients with ESCC. Additionally, the DP regimen was associated with more severe haematological toxicities. This trial has been registered with the US National Institute of Health (clinicaltrials.gov, Identifier NCT 02969473).

Feasibility and efficiency of concurrent chemoradiotherapy with a single agent or double agents vs radiotherapy alone for elderly patients with esophageal squamous cell carcinoma: Experience of two centers

“…The median OS of patients treated with docetaxel or fluorouracil was higher than that reported in Zhang's study (docetaxel, did not reach the median OS vs 21 months; fluorouracil, 22 vs 17 months). Zhu et al did a randomized phase 2 trial comparing definitive concurrent chemoradiotherapy with docetaxel plus cisplatin vs 5‐Fluorouracil plus cisplatin in patients with esophageal squamous cell carcinoma and reported no significant differences in overall survival and progression‐free survival between the two groups, but the docetaxel plus cisplatin regimen was associated with more severe hematological toxicities. Several factors may account for this discrepancy.…”

A predictive model for treatment response in patients with locally advanced esophageal squamous cell carcinoma after concurrent chemoradiotherapy: based on SUVmean and NLR

“…Although CCRT improved local control and overall survival compared with radiotherapy alone, the treatment outcomes of CCRT varied widely. According to data in the literature, the overall response rate (ORR) to CCRT in patients with esophageal cancer ranges from 53.3 to 98.3% [2][3][4]. We can improve this rate by setting individualized treatment strategies and intensities for different subgroups of patients.…”

A study of concurrent chemoradiotherapy with weekly docetaxel and cisplatin for advanced esophageal squamous cell carcinoma with T4 and/or M1 lymph node metastasis or locoregional recurrence

“…3 Overall survival (a), progression-free survival (b) and locoregional control (c) according to enrolled group (newly diagnosed vs. recurrent). OS, overall survival; PFS, progression-free survival neutropenia, thrombocytopenia and anaemia were 57.8, 4.4 and 4.4% [32]. However, in a similar study using weekly docetaxel and cisplatin treatment with CRT, grade 3-4 hematologic toxicity was observed in less than 5% of patients [24].…”